Actively Recruiting
Novel Pilot Study to Treat Symptoms of IBS With Diarrhea Using Combination Therapy of a Low-FODMAP Diet and a Neuromodulator
Led by Mayo Clinic · Updated on 2025-12-18
20
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this research is to study the added benefit of treating IBS symptoms with a medication called mirtazapine in treating IBS symptoms when paired with a low-FODMAP diet compared to a low-FODMAP diet alone. FODMAP stands for fermentable oligosaccharides, disaccharides, monosaccharides, and polyols. These are short-chain carbohydrates that can cause digestive distress in some people. You have been asked to take part in this research because you have symptoms of diarrhea-predominant irritable bowel syndrome that may respond to treatment with a combination of a medication called mirtazapine and a low-FODMAP diet.
CONDITIONS
Official Title
Novel Pilot Study to Treat Symptoms of IBS With Diarrhea Using Combination Therapy of a Low-FODMAP Diet and a Neuromodulator
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 70 years
- Score greater than 175 on the IBS-SSS questionnaire
- Meet Rome IV criteria for IBS with diarrhea (IBS-D)
- Negative urine pregnancy test if capable of becoming pregnant
- Ability to understand and comply with study procedures throughout the study
You will not qualify if you...
- Score less than or equal to 175 on the IBS-SSS questionnaire
- Prior diagnosis of celiac disease, small intestinal bacterial overgrowth, inflammatory bowel disease, or microscopic colitis
- Current significant anxiety or depression
- Known side effect to mirtazapine
- Previous treatment with low-FODMAP diet or mirtazapine without benefit
- Active alcohol or drug abuse
- Inability to read or understand the consent form
- Any other medical or psychological condition preventing study participation
- Pregnant females
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mayo Clinic
Jacksonville, Florida, United States, 32224
Actively Recruiting
Research Team
J
Jessica C Petrov, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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